HSA · registration DE0509560Ortho-Clinical VITROS Immunodiagnostics Products Intact PTH II Reagent Pack
- Registration number
- DE0509560
- Model name
- VITROS Immunodiagnostic Products Intact PTH II Reagent Pack; VITROS Immunodiagnostic Products Intact PTH II Calibrators; VITROS Immunodiagnostic Products Intact PTH II Controls
- Model identifier
- 6900052; 6900053; 6900054
- Registration date
- July 22, 2024
- Risk class
- Class C
- Product owner
- Ortho-Clinical Diagnostics
- Registrant / registration holder
- ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD.
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack quantitatively measures intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin or sodium heparin) using the automated VITROS ECi/ECiQ/ 3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems. Intact PTH is indicated to aid in the diagnosis of hyperparathyroidism, hypoparathyroidism, differential diagnosis of hypocalcemia or hypercalcemia and for intraoperative measurement of iPTH levels.
- Product owner address
- Felindre Meadows, Pencoed, Bridgend, CF35 5PZ, United Kingdom
- Registrant address
- 1 INTERNATIONAL BUSINESS PARK, #01-12, THE SYNERGY, Singapore 609917
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.